Pancreatic Neoplasms Clinical Trial
Official title:
An Open Label, Stratified, Single-arm Phase II Study of Everolimus in Patients With Advanced Pancreatic Neuroendocrine Tumor (NET) After Failure of Cytotoxic Chemotherapy
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in
patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET)
after failure of cytotoxic chemotherapy.
Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will
receive everolimus monotherapy at 10 mg/day.
Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot
treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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